Specimen Retrieval System for Use in Endoscopic Surgery

ABSTRACT

A specimen retrieval system for easier tissue removal during endoscopic surgery. The device includes a specimen tube with a main tube, and a mechanism for pulling and everting the distal end of the tube into the tube, or a side channel provided within the tube. The mechanism may include a tether fixed to the distal edge of the tube, or a grasper operable to grasp the distal edge of the tube.

This application is a continuation of U.S. application Ser. No.16/094,708, filed Oct. 18, 2018, now U.S. Pat. No. 10,835,219, which isa national stage of International Application PCT/US2017/028375, filedApr. 19, 2017, which claims priority to U.S. Provisional Application62/375,055, filed Aug. 15, 2016, and U.S. Provisional Application62/324,802, filed Apr. 19, 2016.

FIELD OF THE INVENTIONS

The inventions described below relate the field of specimen collectionduring endoscopic surgery.

BACKGROUND OF THE INVENTIONS

Endoscopic surgery is often used to remove diseased tissue from theabdomen. During endoscopic surgery of the abdomen, a surgical teaminflates the abdomen to create a surgical workspace, and insertssurgical instruments and an endoscope into the abdomen through severalportals cut through the abdominal wall. In surgeries such as gallbladder removal, tumor removal, and appendectomy, a surgeon will cuttissue from surrounding tissue and remove that tissue from theworkspace. In many cases, it is best to quickly isolate the excisedtissue from the remaining tissue in the workspace, because the tissuemay be infected or cancerous. To isolate the tissue and make it easierto remove it, a surgeon will often insert a specimen bag into theworkspace, place the tissue in the specimen bag, and pull the specimenfrom the workspace through one of the portals used to perform thesurgery.

Current specimen bags used in endoscopic surgery are mere plastic bagsor bags supported by hoops (like fishing nets). Bert™ tissue retrievalbags are unstructured floppy bags. A surgeon will drop the bag into thesurgical workspace, open the bag with a grasper operated through a firstportal and fill the bag with a grasper inserted through a second portal,while using an endoscope inserted through a third portal to visualizethe procedure. Ethicon's EndoPouch® specimen retrieval bag resembles afishing net with a collapsible hoop. The EndoPouch® specimen retrievalbag is inserted through a cannula in a first portal, and isself-opening. A surgeon must use a grasper inserted through a secondportal to grab tissue and drop the tissue into the bag, and must insertan endoscope through a third portal to visualize the procedure.

SUMMARY

The specimen retrieval systems and methods described below provide foreasier tissue removal during endoscopic surgery of the abdomen, andreduces the number of portals needed to retrieve tissue. The specimenretrieval systems include a specimen tube assembly comprising a maintube a tether secured to the distal end of the tube and extendingproximally through the tube and beyond the proximal end of the tube. Thespecimen retrieval systems may also include the specimen tube assemblycomprising the main tube with a side channel tube, a hoop in the distalend of the main tube, with the tether secured to the hoop and extendingthrough the side channel and out of the proximal end of the specimentube. With the distal end of the specimen tube disposed in the abdomenof a patient, the hoop and the distal edge of the main tube can bepulled into the side channel, until a portion of the tube is evertedinto the side channel. When the distal edge of the tube is pulled intothe proximal portion of the tube, and resides outside the patient'sabdomen, the surgeon can pull the specimen tube assembly from theabdomen. Any tissue or fluid in the specimen tube assembly is isolatedfrom the workspace because the specimen tube assembly, in its evertedconfiguration, is closed to the workspace. Any tissue or fluid in thespecimen which might by deposited on the outside of the tube distal end,or the edge of the tube, is also isolated from the workspace uponeversion of the distal end of the tube into the remainder of the tube.

While the use of the specimen tube assembly is described below inreference to abdominal endoscopic surgery, the specimen tube assemblyand its method of use may be used to retrieve tissue or objects from anysurgical or natural workspace of the body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a specimen tube assembly operable to partially evertto provide an enclosure for specimens obtained in a surgical workspace.

FIG. 2 is a detail of the distal end of the tube, illustrating anarrangement of the hoop and tether.

FIG. 3 is a detail of the distal end of the tube, illustrating anarrangement of the hoop and tether.

FIG. 4 is a detail of the distal end of the tube, illustrating anarrangement of the hoop and tether.

FIG. 5 is a view of the specimen tube assembly, illustrating placementof the device in a surgical workspace.

FIG. 6 is a view of the specimen tube assembly, illustrating insertionof a grasper, through the specimen tube assembly proximal end and intothe workspace.

FIG. 7 is a view of the specimen tube assembly, illustrating drawback ofthe grasper to place a piece of tissue from the workspace into thespecimen tube assembly.

FIG. 8 is a view of the specimen tube assembly, illustrating initialpullback of the tether, to draw the hoop into the side channel.

FIG. 9 is a view of the specimen tube assembly, illustrating a furtherpullback of the tether to draw the hoop proximally within the sidechannel and draw the open distal end of the tube into the side channel.

FIG. 10 is a view of the specimen tube assembly, illustrating a furtherpullback of the tether to draw the hoop proximally within the sidechannel to reside outside the workspace.

FIG. 11 illustrates withdrawal of the specimen tube assembly from theworkspace.

FIG. 12 illustrates a simple version of an everting specimen tubeassembly with a tether.

FIG. 13 illustrates a stick for use with the everting specimen tubeassembly of FIG. 12.

FIG. 14 illustrates the specimen tube assembly of FIG. 12, with a shortportion of the distal end of the bag everted within the bag.

FIG. 15 illustrates the specimen tube assembly of FIG. 12, with thestick of FIG. 13 inserted in the bag and the tether threaded through theguide ring of the stick.

FIG. 16 is a view of the specimen tube assembly of FIG. 12, illustratinginsertion of a grasper, through the specimen tube assembly proximal endand into the workspace.

FIG. 17 is a view of the specimen tube assembly of FIG. 12, illustratingdrawback of the grasper to place a piece of tissue from the workspaceinto the specimen tube assembly.

FIG. 18 is a view of the specimen tube assembly of FIG. 12, illustratinginitial pullback of the tether, to draw the hoop into the guide ring ofthe stick.

FIG. 19 is a view of the specimen tube assembly of FIG. 12, illustratinga further pullback of the tether to draw the hoop proximally within theguide ring and draw the open distal end of the tube through the guidering.

FIG. 20 is a view of the specimen tube assembly of FIG. 12, illustratinga further pullback of the tether to draw the hoop proximally within thetube to reside outside the workspace.

FIGS. 21 through 24 illustrate an embodiment of a specimen tube assemblywith rigid or semi-rigid tube in place of the side channel of the deviceof FIGS. 1 through 11.

FIGS. 25 through 28 illustrate an embodiment of a specimen tube assemblywhich is used in conjunction with a grasper and cannula, to draw thedistal edge of the bag into the cannula before pulling the bag from theworkspace.

FIGS. 29 and 30 illustrates a specimen tube assembly operable topartially evert to provide an enclosure for specimens obtained in asurgical workspace, held open with inflatable channels.

FIGS. 31 and 32 illustrate the configuration of the specimen tubeassembly of FIG. 29 when inflated.

FIG. 33 is a view of the specimen tube assembly of FIGS. 29 and 31,illustrating placement of the device in a surgical workspace.

FIG. 34 is a view of the specimen tube assembly of FIGS. 29 and 31,illustrating inflation of the inflatable channels and expansion of thedevice within a surgical workspace.

FIG. 35 is a view of the specimen tube assembly of FIGS. 29 and 31,illustrating initial eversion of the skirt into the lumen of the ofdevice.

FIG. 36 is a view of the specimen tube assembly of FIGS. 29 and 31,illustrating initial deposit of the specimen into the lumen of thedevice.

FIG. 37 is a view of the specimen tube assembly of FIGS. 29 and 31,illustrating eversion of the skirt and distal portions of the inflatablechannels into the lumen of the device.

FIG. 38 illustrates withdrawal of the specimen tube assembly of FIGS. 29and 31 from the workspace.

FIG. 39 illustrates various features of the specimen tube which may beused in any of the embodiments disclosed in the previous figures.

DETAILED DESCRIPTION OF THE INVENTIONS

FIG. 1 illustrates a specimen tube assembly operable to partially evertto provide an enclosure for specimens obtained in a surgical workspace.As shown in FIG. 1, the specimen tube assembly 1 comprises a main tube2, with a distal end 2 d and a proximal end 2 p, and a side channel tube3, secured within the main tube, with a distal end 3 d terminating nearthe distal end 2 d of the main tube (preferably a short distanceproximal to the distal edge 2 e of the main tube), and a proximal end 3p terminating proximate the proximal end 2 p of the main tube. Asemi-rigid or resilient hoop 4 is secured to the distal end of the tube,circumscribing the opening at the distal end. The hoop may be capturedin a hem formed by doubling or turning over the edge of the tube onitself and securing it to the tube to create a channel in which the hoopresides, or the hoop may be glued or melted to the tube, or the hoop maybe integrally formed with the tube. The hoop may be a complete orpartial ring. Preferably, the hoop 4 is semi-rigid, with sufficient hoopstrength to open the distal end of the tube when unconstrained, and,preferably, a hoop strength greater that the hoop strength of the tube2. A tether 5 is disposed within the side channel 3, extending frombeyond the distal end of the side channel to the proximal end of theside channel and beyond. The tether may be discrete or integrally formedwith the hoop. (The loop and tether may be also formed as a lasso, withan eye of the lasso located where the joint between the hoop and thetether is depicted, and the lasso loop corresponding to the hoop and thelasso spoke corresponding the tether.) At the distal end 5 d of thetether, the tether is secured to the hoop 4. The proximal end 5 p of thetether extends proximally to the proximal end of the side channel andthe main tube, and proximally out of the proximal end of both the sidechannel and the main tube. A pull ring 6 may be attached to the proximalend of the tether. An additional ring 7 may be disposed at the proximalend or edge of the main tube. This additional ring is preferably rigidor semi-rigid, to hold the proximal end open as needed to accommodatelaparoscopic instruments. As illustrated, the proximal end 2 p of themain tube is funnel-shaped, with a small diameter segment relative tothe distal end of the main tube. However, the main tube distal andproximal openings may be roughly the same size.

FIGS. 2, 3 and 4 illustrate versions of the distal edge of the tube. Asshown in FIG. 2, the distal end may be square cut, with the tethersecured to the hoop at a point within an arcuate region of the hoopradially proximate the side channel 3. In FIG. 2, the arcuate portion ofthe hoop at which the tether is attached is biased to curve slightlyproximally, to facilitate entry of the hoop 4 into the side channel. Asshown in FIG. 3, the distal end may be square cut, with the tethersecured to the hoop at a point within an arcuate region of the hoopradially spaced, preferably radially opposite, the side channel. In FIG.3, the arcuate portion of the hoop at which the tether is attached iscurved slightly distally, to facilitate entry of the hoop into the sidechannel on the opposite side of the main tube. As shown in FIG. 4, themain tube distal end 2 is bevel-cut, with a pointed distally extendingportion 2 x radially opposite the side channel, and the tether securedto the hoop at a point proximate the pointed region, preferably at thepoint. The tether in this illustration is secured to the hoop at a pointwithin an arcuate region of the hoop radially spaced, preferablyradially opposite, the side channel.

The use of the specimen tube assembly is explained in FIGS. 5 through11. A user, such as a surgeon, will perform each step to isolate andremove a portion of body tissue that has been dissected from surroundingtissue. As shown in FIG. 5, a surgeon has inserted the specimen tubeassembly 1 into the surgical workspace 8 through a cannula or portal 9which has been placed in an incision in the skin overlying the surgicalworkspace, such that the distal end 2 d of the main tube is disposed inthe workspace 8, the proximal end 2 p of the main tube is disposedoutside the body of the patient, with a central portion 2 c disposed inthe cannula/portal. The hoop 4 is sufficiently resilient to hold thedistal end of the main tube open when unconstrained. The tether proximalend 5 p and pull ring 6 remain outside the body. Placement of the distalend of the specimen tube assembly may be observed with an endoscopiccamera, inserted into the surgical workspace through a second portal.

As shown in FIG. 6, the surgeon inserts a grasper 10 into the bag, fromthe proximal end, to position the grasping jaws of the grasper in theworkspace. The surgeon then grasps the body tissue, item 11, and pullsit into the main tube, as shown in FIG. 7. The surgeon may then withdrawthe grasper completely from the specimen tube assembly, or may leave thegrasper in place, with the tip of the grasper within the distal portionof the bag, to be used as a rigid element to facilitate eversion in thenext steps. The grasper is preferably freely movable within the tube,but it may be secured to the proximal end of the tube by the additionalring 7, using an elastic ring, or by fixing the ring to the grasper withadhesive.

As shown in FIG. 8, the surgeon pulls the tether proximally, using theproximal portions 5 p of the tether (and the pull ring 6, if provided),to draw the hoop into the side channel. FIG. 8 shows the hoop justentering the side channel, while FIG. 9 shows the device with the hoopdrawn almost entirely into the side channel, such that the open edge ofthe main tube is almost entirely located within the side channel and thebody tissue. When the hoop 4 is entirely within the side channel, it isisolated from the workspace by the remaining exposed side wall 12 of themain tube. The eversion which occurs in these steps may be facilitatedwith the grasper, holding the grasper in place in the main tube distalend to provide a rigid post over which the main tube material can slidewhile everting. The grasper may also be used to hold the side channel inplace during eversion of the distal portion of main tube into the sidechannel. However, as illustrated, the grasper is not necessary toaccomplish the method.

In FIG. 10, the surgeon has pulled the tether 5 and hoop 4 proximallywithin the side channel, until the hoop 4 and distal end 2 d of the maintube are located entirely outside the body. At this point, any fluids ordiseased cells that leak from the distal end of the main tube will spilloutside the workspace. Finally, the surgeon will pull the entirespecimen tube assembly out of the workspace. Finally, as shown in FIG.11, entire tube, in its everted configuration, with the portion of bodytissue contained within the everted tube, can be pulled from theworkspace through the incision. The everted distal end of the bag, andthe proximal end of the bag, may be tied closed before withdrawal, andthe cannula may be withdrawn with the bag or it may be withdrawn beforepulling the bag from the workspace.

FIG. 12 illustrates a simple version of an everting specimen tubeassembly with a tether. In this embodiment, the specimen tube assembly21 comprises a tube 22 with a distal end 22 d and a proximal end 22 pwith a tether 23 with a distal end 23 d and a proximal end 23 p. Thetether is secured to the distal edge 22 e of the specimen tube assemblytube 22, optionally to a hoop 24. The tether runs proximally through thetube 22 (no side tube is used in this embodiment), to extend out theproximal opening of the tube 22. The hoop 24 and tether 23 can be formedintegrally or separately, and one or both can be semi-rigid andresilient, like a collapsible O-ring, or limp and non-elastic, likenylon thread or suture. Preferably, the hoop 24 is semi-rigid, withsufficient hoop strength to open the distal end of the tube whenunconstrained, and, preferably, a hoop strength greater that the hoopstrength of the tube 22. As with the previous embodiment, the ringdisposed at the distal end of the tube can be hemmed into the distalend, glued to the distal end, melted to the distal end, or formedintegrally with the distal end. A pull ring 25 may be attached to theproximal end of the tether. As appears from comparison of FIGS. 1 and12, the hoops 4 and 24 and their corresponding tethers may interchangedand used with the various embodiments depicted in the drawings.

FIG. 13 illustrates a rod for use with the everting specimen tubeassembly of FIG. 12. The rod 26 has blunt rounded distal tip 27, and asecond, semi-rigid guide ring 28 located on near the distal end 26 d ofthe rod. The proximal end 26 p of the stick extends out of the proximalend of the bag 22. The guide ring is preferable resiliently deformable,so that it may be compressed to a small configuration to fit through aportal and expand once release from the portal inside the workspace, asshown in the following figures.

FIG. 14 illustrates the specimen tube assembly of FIG. 12, with a shortportion of the distal end of the bag everted within the bag. The distaledge is shown folded to the inside of the tube, to form an everted cuff.The process of eversion is used to effectively close off the tube fromthe workspace, as in the previously described specimen tube assembly,but without the use of the inner channel 3 used FIGS. 1 through 11.

The use of the specimen in conjunction with the rod is illustrated inthe following figures.

FIG. 15 illustrates the specimen tube assembly of FIG. 12, with the rod26 of FIG. 13 inserted in the bag and the tether threaded through thesemi-rigid guide ring 28 of the rod 26. A user, such a surgeon, willperform each steps to isolate and remove a portion of body tissue thathas been dissected from surrounding tissue. As shown in FIG. 15, asurgeon has inserted the specimen tube assembly 22 into the surgicalworkspace 8 through a cannula or portal 9 which has been placed in anincision in the skin overlying surgical workspace, such that the distalend 22 d of the main tube is disposed in the workspace 8, the proximalend 22 p of the main tube is disposed outside the body of the patient,with the central portion 22 c disposed in the cannula/portal. The hoop24 in the hem at the distal edge 22 e is preferable sufficientlyresilient to hold the distal end of the main tube open. The tetherproximal end 23 p and pull ring 25 (see FIG. 12) remain outside thebody. Placement of the specimen tube assembly may be observed with anendoscopic camera, inserted into the surgical workspace through a secondportal.

FIG. 16 is a view of the specimen tube assembly of FIG. 12, illustratinginsertion of a grasper 10, through the specimen tube assembly proximalend and into the workspace. FIG. 17 is a view of the specimen tubeassembly of FIG. 12, illustrating drawback of the grasper to place apiece of tissue from the workspace into the specimen tube assembly. Asurgeon, after having placed the bag, inserts the rod 26 and ring 28into the distal portion of the bag, and also inserts a grasper 10 intothe bag, from the proximal end, to position the grasping clamps of thegrasper in the workspace. The surgeon then grasps the body tissue andpulls it into the main tube, as shown in FIG. 17. The surgeon may thenwithdraw the grasper completely from the specimen tube assembly, or mayleave the grasper in place, with the tip of the grasper within thedistal portion of the bag, to use as a rigid element to facilitateeversion in the next steps.

FIG. 18 is a view of the specimen tube assembly of FIG. 12, illustratinginitial pullback of the tether, to draw the hoop 24 into the semi-rigidguide ring 28 of the stick, while FIG. 19 is a view of the specimen tubeassembly of FIG. 12, illustrating a further pullback of the tether todraw the hoop 24 proximally within the guide ring 28 and draw the opendistal end of the tube through the guide ring 28. As shown in FIG. 18,the surgeon pulls the tether proximally, using the proximal portions 23p of the tether (and the pull ring 25, if provided), to draw the hoop 24into the tube 22 and guide ring 28. FIG. 18 shows the hoop 24 justentering the ring 28, while FIG. 19 shows the device with the hoop 24drawn entirely into the tube, proximal to the guide ring 28, such thatthe open edge of the main tube is entirely located within the tubeitself and the body tissue is isolated from the workspace by theremaining exposed side wall 12 of the main tube. The eversion whichoccurs in these steps may be facilitated with the blunt end of the rodor the grasper, holding the rod or grasper in place in the main tubedistal end to provide a rigid post over which the main tube material canslide while everting through the hoop 24.

FIG. 20 is a view of the specimen tube assembly of FIG. 12, illustratinga further pullback of the tether to draw the hoop 24 proximally withinthe guide ring to reside outside the workspace. In FIG. 20, the surgeonhas pulled the tether and hoop 24 proximally within the tube, until thehoop 24 and distal edge of the main tube are located entirely outsidethe body. At this point, any fluids or diseased cells that leak from thedistal end of the main tube will spill outside the workspace. Finally,the surgeon will pull the entire specimen tube assembly out of theworkspace. The everted distal end of the bag, and the proximal end ofthe bag, may be tied closed before withdrawal, and the cannula may bewithdrawn with the bag or it may be withdrawn before pulling the bagfrom the workspace.

FIGS. 21 through 24 illustrate an embodiment of a specimen tube assemblywith rigid or semi-rigid tube in place of the side channel of the deviceof FIGS. 1 through 11. In FIG. 21, the specimen tube assembly 29, againwith main tube 30 with a distal end 30 d and a proximal end 30 p, and aside channel tube 31, secured within the main tube, with a distal end 31d terminating near the distal end 30 d of the main tube 30 (preferably ashort distance proximal to the distal end of the main tube), and aproximal end 31 p terminating proximate the proximal end 30 p of themain tube. An elastic band 32 in the proximal end of the main tube maybe provided to hold the proximal edge tight to a grasper. A semi-rigidor resilient hoop 4 may be secured to the distal end of the tube,circumscribing the opening at the distal end. As in FIG. 1, the hoop maybe captured in a hem formed by doubling or turning over the edge of thetube on itself and securing it to the tube to create a channel in whichthe hoop resides, or the hoop may be glued, melted, or integrally formedwith the tube. The hoop may be a complete or partial hoop. Preferably,as in the previously described embodiments, the hoop 4 is semi-rigid,with sufficient hoop strength to open the distal end of the tube whenunconstrained, and, preferably, a hoop strength greater that the hoopstrength of the tube 30. A tether 33 is disposed within the rigid sidechannel 31, extending from beyond the distal end of the side channel tothe proximal end of the side channel and beyond. At the distal end 33 dof the tether, the tether is secured to the hoop 4. The proximal end 33p of the tether extends proximally to the proximal end of the sidechannel and the main tube, and proximally out of the proximal end ofboth the side channel and the main tube. A pull ring 34 may be attachedto the proximal end of the tether. In this device, the side channel tube31 is rigid or semi-rigid, sufficient to hold the bag suspended. Thehoop 4 secured to the distal edge is resilient, and biased to an openconfiguration. As shown in FIG. 22, the specimen tube assembly has beeninserted into a workspace 8, through an incision in the abdominal wallof a patient and a cannula/portal 9 in that incision, with the distalend of tube 30 d disposed in the workspace and the proximal end of thetube disposed outside the workspace. The grasper has been inserted,through the tube and cannula, and used to grasp a portion of body tissueto withdraw it into the side channel tube 30. As shown in FIG. 23, thegrasper has been withdrawn, and the tether has been pulled proximally todraw the hoop 4 into the rigid side channel tube. Depending on the sizeof the side channel tube and its rigidity, the hoop 4 may be pulledentirely into the distal end of the side channel tube 30, but nofurther, or it may be withdrawn further proximally into the side channeltube 30 such that the hoop 4, and the distal edge of the main tube,reside outside the body. With the distal edge disposed within the rigidside channel tube, as shown in FIG. 24, the specimen tube assembly maybe pulled from the workspace.

FIG. 25 illustrates a simpler device useful in a method illustrated inthe following figures. The device of FIG. 25 includes a tube 35 with anopen distal end supported by a hoop 36, and a proximal end secured tothe shaft of a grasper 10. The proximal end may be of smaller diameter,to match the outer diameter of the grasper (as in FIGS. 1 through 11),or of large diameter comparable to the distal end (as in FIGS. 12through 20). Preferably, as in the previously described embodiments, thehoop 36 is semi-rigid, with sufficient hoop strength to open the distalend of the tube when unconstrained, and, preferably, a hoop strengthgreater that the hoop strength of the tube 35. As shown in FIG. 26, asurgeon inserts the distal end 35 d of the tube 35, and the hoop 36,into the workspace, through an opening into the workspace. The surgeonalso inserts the grasper through the tube, so that it extends distallyinto the workspace. This may be done in separate steps (for example,using a cannula to insert the bag, and then inserting the grasperthrough the bag), or it may be conveniently done by grasping the hoopwith the grasper, from inside the tube, and pushing the hoop and tubethrough the cannula 9 (or inserting the tube through the opening,without using a cannula), and shown in FIG. 26. With the distal end ofthe tube in place, and the grasper in place within the workspace, thesurgeon manipulates the grasper to grasp a portion of body tissue andpull the portion of body tissue into the tube, as shown in FIG. 27. Thetube may be held with a second grasper to facilitate placement of bodytissue into the tube. With the body tissue within the tube, the surgeongrasps the distal end of tube (for example, by grasping the hoop) withthe grasper, as shown in FIG. 28, and pulls the distal end of the tubeand/or the hoop through the cannula, leaving a loose portion of the tubein the workspace and pulling the distal end through the cannula and outof the workspace. With the distal end and the proximal end of the tubeoutside the workspace, the surgeon pulls the entire specimen tubeassembly out of the workspace. With this device, the bag need not evertfully before withdrawal, and is sufficient that the distal end of thetube be effectively closed and/or withdrawn from the workspace. Also,the grasper may be inserted side-by-side with the tube, rather thaninside the tube, so that upon withdrawal of the grasper and the distaledge of the bag (including the hoop), the bag is folded, rather thanturned inside-out, with a central portion of the tube containing thetissue portion.

FIG. 29 illustrates a specimen tube assembly 41 operable to partiallyevert to provide an enclosure for specimens obtained in a surgicalworkspace, with inflatable channels which may be inflated to cause thespecimen tube assembly to take on a generally cylindrical configurationin the region which, while in use, will reside in the surgicalworkspace. The overall construction of the specimen tube assembly 41 issimilar to the specimen bag assembly of FIG. 1, and includes a main tube41, with a distal end 41 d and a proximal end 41 p. The distal end 41 d,intended to be inserted into the endoscopic workspace, is substantiallyisodiametric throughout its length (when inflated). The proximal end 41p, intended to remain in the insertion cannula and extend to the outsidethe workspace when the device is in use, may be tapered as shown, or mayalso be isodiametric. A tether or flexible cord 5 circumscribes thedistal end of the tube in a loop 5L, and, as with previous figures, theloop may be captured in a hem or casing (a channel with an opening,through which the loop may drawn), which may be formed by doubling orturning over the edge of the tube on itself and securing it to the tubeto create a channel in which the tether resides, or the loop may beglued or melted to the tube, or the hoop may be integrally formed withthe tube. The tether may completely or partially circumscribe theopening of the tube, secured to the distal edge 41 e. (A semi-rigid orresilient hoop secured to the distal end of the tube, circumscribing theopening at the distal end (such as hoop 4 of the previous figures), maybe used in place of the loop portion of the tether, though absence ofhoop strength of the tether, comprised of thread, string or suture,facilitates eversion in this embodiment.) The tether 5 runs distallythrough the specimen tube assembly, through the main open space of thespecimen tube assembly (though it may be is disposed within a sidechannel, extending from the loop, into the distal end of the sidechannel to the proximal end of the side channel and beyond). The tethermay be discrete or integrally formed with the loop. (The loop and tethermay be also formed as a lasso, with an eye of the lasso located wherethe transition from the loop portion to the running portion is depicted,and the lasso loop corresponding to the loop portion and the lasso spokecorresponding the running portion of the tether.) The tether extendsproximally to the proximal end of the specimen tube assembly andproximally out of the proximal end of the specimen tube assembly. A pullring 6 may be attached to the proximal end 5 p of the tether. (Anadditional ring, such as ring 7 shown in the earlier figures, may bedisposed at the proximal end or edge of the main tube. This additionalring is preferably rigid or semi-rigid, to hold the proximal end open asneeded to accommodate laparoscopic instruments.) As illustrated, theproximal end 41 p of the specimen tube assembly is funnel-shaped, with asmall diameter segment relative to the distal end 41 d of the specimentube assembly. However, the specimen tube distal and proximal openingsmay be roughly the same size, and the tube can be isodiametricthroughout its length. Also, the distal end need not be isodiametric,though this construction facilitates eversion.

The specimen tube assembly 41 of FIG. 29 includes several inflatablechannels 42, extending longitudinally along the main tube 41. Asillustrated, the inflatable channels extend along a distal portion 41 dof the main tube, and preferable terminate proximally before theproximal end 41 p (the funnel-shaped portion) of the tube, so that theproximal portion of the main tube is devoid of inflatable channels, soas to minimize the thickness of the proximal portion (the proximalportion of the main tube remains within the cannula when the distalportion is disposed within the endoscopic workspace). An inflation lumen43 communicates from one or more of the side channels, and runsproximally from the side channel(s) to the proximal end of the maintube, where it can be attached to a pump or syringe 44 operable toinflate the side channels (a ball pump will suffice, but any means forinflating may be used, or the pump may be omitted and the device may beinflated by mouth through a length of tubing). Multiple channels 42 canbe fed with inflation fluid through a proximal manifold 45, using asingle inflation tube. A distal manifold 46, in fluid communication withthe distal ends of the several inflatable channels, may be provided toprovide fluid communication between the several inflatable channels attheir distal ends. The distal manifold and proximal manifold canfacilitate inflation and deflation of the inflatable channels (so that asingle inflation lumen may be used). Distal to the distal ends of thechannels 42, or the distal manifold 46 (if provided), the main tube mayextend distally, without the presence of inflatable channels, in a skirtor edging 47, which is easily everted into the inner volume of thespecimen tube assembly. Between each longitudinally extending inflatablechannel, a longitudinal extending non-inflatable region 48 of the maintube may be provided. Also, each inflatable channel may be perforated,with a small aperture 49, communicating from the lumen of the channel tothe outside channel, either to the outside (as shown) or the inside ofthe main tube.

FIG. 31 illustrates the configuration of the specimen tube assembly ofFIG. 29 when inflated. Each inflatable channel is bulging due to thepressure of fluid pumped into the channel. Where apertures 49 areprovided in the channels, the channels will inflate, and remaininflated, so long as the fluid is provided at a high rate, compared tothe leakage through the apertures. As shown, the inflatable channels,when inflated, provide sufficient rigidity/hoop strength or bendingstiffness to the specimen tube assembly to hold the very distal endopen. FIG. 30 shows, in cross section, the configuration of the specimentube assembly in the region of the inflatable channels when theinflatable channels 42 are not inflated, so that the tube may becompacted with an insertion cannula, while FIG. 32 shows theconfiguration of the specimen tube assembly when the inflatable channelsare inflated and the specimen tube assembly is expanded. In the inflatedconfiguration, the inflatable channels 42 are distended, as shown inFIG. 32, and hold the main tube in a roughly open cylindricalconfiguration. The tube, in the region of the inflatable channels, needonly be open enough to hold the distal fringe open enough to allowintroduction of a tissue specimen, from the workspace, with minimal orno manipulation of the distal opening of the specimen tube assembly fromoutside the specimen tube assembly, or with an endoscopic tool insertedthrough a separate portal (other than the possible circumstance in whichpulling the specimen into the specimen tube assembly catches the fringeand deflects it toward an everted configuration).

The materials and dimensions of the specimen tube assembly of FIGS. 29and 31 may vary according to the size of the expected specimen to becollected and the size of the workspace. For retrieval of a gall bladderfrom the abdomen of a patient, the specimen tube assembly may beprovided in configuration with five inflatable channels dispersed aboutthe circumference of the specimen tube assembly, with a flat,non-inflatable region between each inflatable channel. For otherapplications, a single narrow channel spanning a small circumferentialarc of the specimen tube assembly may be used, and in other applicationsseveral or many channels 42 may be provided, with or without interveningflats 48.

The specimen tube assembly may be made of various materials, and asuitable fabrication comprises two layers, or two tubes, each comprisinga nylon film, a polyurethane film, or a fabric. The specimen tubeassembly of FIGS. 29 and 31 can be fabricated with two tubes of nylonfilm, one disposed within the other, and heated sealed or meltedtogether in the areas corresponding to the flats 48, the skirt 47, andthe non-inflatable regions proximal to the proximal manifold or theproximal ends of the inflatable channels. Alternatively, each inflatablechannel, manifold and inflation lumen may be formed individually, byadhering a strip of material, or an entire discrete tube, to the inneror outer surface of the main tube. The base layer of the tube, forexample a nylon fabric, may be coated with a first layer of urethane,and a second layer of silicone.

Suitable dimensions for the specimen tube assembly, for use in gallbladder retrieval are about six inches (15 cm) long and five inches (13cm) wide (when laid flat, which provides about 3.2 inch (8 cm) lumenwhen expanded), with five inflatable channels about 1″ (2.5 cm) widedispersed about the circumference of the specimen tube assembly, withflats of about 1 inch (2.5 cm) wide between each inflatable channels.The skirt may extend 1 or 2 inches (2.5 to 5 cm) distally from thedistal end of the inflatable channels. This size, when fabricated withnylon film with a wall thickness of about 6 mil (for a combined wallthickness of 12 mil), will fit through a 12 mm (ID) trocar typicallyused for endoscopes and staplers, and may be used to retrieve a specimenof about 1.5″ by 4″ (a typical gall bladder). The dimensions may beadjusted to make the specimen tube assembly suitable for otherapplications, such as removal of portions of the stomach.

FIGS. 33 through 38 illustrate the use of the specimen tube assembly ofFIGS. 29 and 31. A user, such as a surgeon, will perform each step toisolate and remove a portion of body tissue that has been dissected fromsurrounding tissue. For insertion through a cannula, the specimen tubeassembly 41 is tightly wrapped around an obturator and passed throughthe cannula. As shown in FIG. 33, a surgeon has inserted the specimentube assembly 41 into the surgical workspace 8 through a cannula orportal 9 which has been placed in an incision in the skin overlying thesurgical workspace, such that the distal end 41 d and distal portion ofthe specimen tube assembly 41 is disposed in the workspace 8, the veryproximal end 41 p of the specimen tube assembly is disposed outside thebody of the patient, with a portion of the proximal end 41 p is disposedin the cannula/portal. The loop 5L of tether 5, if comprised of suture,is insufficiently resilient to hold the distal end of the specimen tubeassembly open, so the specimen tube assembly will typically be collapsedand floppy in its un-inflated configuration. The tether proximal end 5 pand pull ring 6 remain outside the body. Placement of the distal end ofthe specimen tube assembly may be observed with an endoscopic camera,inserted into the surgical workspace through a second portal, or throughthe same cannula 9 used for the specimen tube assembly.

As shown in FIG. 34, after insertion of the specimen tube assembly andplacement of the distal portion in the workspace, the surgeon operatesthe pump or syringe 44 to inflate the inflatable channels 42. Uponinflation of the channels, the specimen tube assembly takes on an openconfiguration as shown in FIG. 31, in the skirt 47 and distal edge 41 eare held open sufficiently to allow passage of a grasper jaws in theopening, allow passage of a tissue specimen into the now open centrallumen of the specimen tube assembly.

As shown in FIG. 35, the surgeon has pulled the skirt 47 into the lumenof the specimen tube assembly, by pulling proximally on the proximal end5 p of the tether. (Initial eversion of the skirt may also be causedwhen the surgeon pulls the tissue into the lumen, if the tissue catchesthe skirt). In this configuration, the skirt is everted into the mainlumen of the specimen tube, such that inner surface of the tube in theregion of the skirt now opposes the inner surface of the tube in themore proximal region of the tube distal portion 41 d. This step may beperformed before or after the steps of pulling a specimen into the tube.

As shown in FIG. 36, the surgeon inserts a grasper 10 into the specimentube assembly, from the proximal end, to position the grasping jaws ofthe grasper in the workspace. The surgeon then grasps the body tissue,item 11, and pulls it into the specimen tube, and releases the tissuewithin the lumen of the specimen tube assembly. The grasper ispreferably freely movable within the tube, but it may be secured to theproximal end of the tube by the additional ring 7 (shown in the previousfigures), using an elastic ring, or by fixing the ring to the grasperwith adhesive.

As shown in FIGS. 36 and 37, the surgeon pulls the tether proximally,using the proximal portions 5 p of the tether (and the pull ring 6, ifprovided), to draw the skirt into the open lumen of the specimen tubeassembly. FIG. 36 shows the skirt just entering the lumen of thespecimen tube assembly, while FIG. 37 shows the device with the skirtdrawn entirely into the lumen, and the distal portions of the inflatablechannels everted into the lumen, create an everted portion of the tubewithin an un-everted portion of the tube. As depicted in FIG. 37, thetissue 11 is trapped between the inner wall of the everted distalportion of the specimen tube assembly and the inner wall of the moreproximal un-everted portion of the distal portion of the specimen tubeassembly. With the specimen securely trapped, the specimen tube assemblyneed not be maintained in the expanded configuration. The surgeon atthis point, when the specimen is sufficient secure, opens the inflationlumen (opening a bleed valve or just disconnecting the ball pump), andbegins bleeding fluid from the inflatable channels (the process ofdeflation can be started at any time in the overall procedure after thespecimen is pulled into the specimen tube assembly). The surgeon maycontinue pulling proximally on the tether, to compress the inflatablechannels and force fluid more quickly from the inflatable channels. Theapertures 49, if provided, will facilitate deflation by allowing fluidto escape through an additional route, especially if the channels arecollapsed so as to close off flow to the proximal manifold and inflationlumen. The surgeon may also operate an associated pump to evacuate theinflatable channels. When the specimen tube assembly is sufficientlydeflated, and the tube sufficiently everted to avoid or minimize leakageof any fluid or tissue associated with the retrieved tissue, the surgeonpulls the specimen tube assembly from the body, taking advantage of theelasticity of the skin to pull even large specimens through the smallskin incision. The cannula/portal may be removed prior to removal of thespecimen tube assembly, or with the specimen tube assembly.

FIG. 38 illustrates withdrawal of the specimen tube assembly from theworkspace of FIGS. 29 and 31. With the specimen securely trapped betweenthe everted distal portion of the specimen tube assembly and theun-everted remainder of the specimen tube assembly, with the now-foldedportion 50 isolating the specimen from the workspace, the surgeon cancontinue to collapse the specimen tube assembly, and pull the collapsedor semi-collapsed specimen tube assembly through the incision, forcingthe incision and surrounding skin to stretch as necessary to allowpassage of the specimen tube assembly and specimen from the workspace.

FIG. 39 illustrates various features of the specimen tube which may beused in any of the embodiments disclosed in the previous figures. Thespecimen tube of FIG. 39 includes the main tube 24 and distal skirt 47with the semi-rigid or resilient hoop 4 secured to the skirt at thedistal end 24 d of the tube, circumscribing the opening at the distalend, and the tether 5 secured to the hoop and running through the lumenof the tube proximally, and extending from the proximal end 24 p of thetube. The hoop is captured in a hem, formed in the skirt, which ismodified with the several scalloped cut-outs 51. These cutouts may aidin cinching the distal opening and drawing and everting the cinched heminto the inside of the tube. The tube is constructed of two flatrectangular pieces of plastic, secured to each other along welded seams52. The hem in this device comprises a plastic film of reducedthickness, compared to the main tube, to facilitate cinching andeversion. For example, the main tube 24 may comprise polyurethane at 2.2mil thickness, while the hem (which comprises a skirt, similar to theskirt of the inflatable embodiments) and distal tip comprisepolyurethane at 1.2 mil thickness. The additional thickness of the maintube may be uniform around the circumference of the tube, ornon-uniform, in which case one or more longitudinal stays, formedintegrally with the remainder of the main tube but with a thicker wallthickness, will serve to stiffen the main tube relative to the skirt orhem at the distal end of the device. (Thus, several means for stiffeningthe main tube relative to the skirt include the extra wall thicknessdescribed here, the inflatable channels described in relation to FIG.29, and the stay described in relation to FIG. 21.)

Referring again to FIG. 39, one or more apertures 53, which may bereinforced by grommets 54 provide a reinforced grasping feature, whichmay be grasped by graspers from within the tube to help push the tubethrough a cannula and adjust the tube during use. Various other graspingfeatures may be used, including a pocket, a small loop, or a flap or tab55 on the inside of the tube, or an area of thicker material which maybe grasped without risk of tearing, while not occupying much of the tubearea to significantly affect eversion. Grasping features may also beadded to the exterior of the tube, especially at the distal end, such asgrasping tab 56 or grasping loop 57, and these may be used to grasp thetube from the outside, even while disposed within the endoscopicworkspace, with graspers introduced into the endoscopic workspacethrough a separate portal. The apertures 53 may also serve as externalgrasping features.

The device of FIG. 39 may be inserted into the surgical workspacethrough a cannula, as described above in relation to the embodimentsdescribed in the earlier figures. To insert the distal end of the deviceinto the workspace, the surgeon will grasp the internal grasping feature(a grommet, pocket, loop or flap) and use the grasper to push the distalend of the tube through a cannula or skin incision into the workspace.After the distal end is disposed in the surgical workspace, the surgeonusing the device to retrieve a specimen may use a grasper to grasp theinternal grasping feature to adjust the tube as necessary. Also, thesurgeon may insert a grasper into the workspace through an additionalportal, approach the tube from outside the tube, and grasp the externalgrasping feature (the tab, or the grommet, or a loop or flap) tomanipulate the tube, for example, to hold the tube up and open whileusing another grasper to grasp a specimen and deposit it into theinterior of the tube. After depositing the specimen in the tube, thesurgeon can again grasp the internal grasping feature or the externalgrasping feature and manipulate the tube to facilitate eversion whilepulling proximally on the tether to evert the skirt portion of the tubeinto the main portion of the tube, and fully evert the tube.

Various structures for accomplishing beneficial functions can beinterchanged while obtaining the benefit of various inventive aspects ofthe various embodiments disclosed above. The benefits of the evertingtube as a means for isolating and withdrawing a specimen can be achievedwith the several means for holding the distal end of the specimen tubeassembly open, including the semi-rigid hoop of FIG. 1, the semi-rigidtube of FIGS. 21 through 24, the grasper of FIG. 26, or the inflatablechannels of FIGS. 29 and 31. The benefits of the everting tube as ameans for isolating and withdrawing a specimen can be achieved with theseveral means for everting the tube, including the hoop and tethercombination of FIG. 1, the grasper of FIG. 26, and the loose, flexiblesuture of FIGS. 29 and 31.

The specimen retrieval system is described above in various embodimentsmay comprise the tube and a tether fixed to the distal end of the tube,with the tether extending from the distal end of the tube, proximallythrough the tube, and extending out the proximal end of the tube. Thespecimen retrieval system may instead comprise the tube and a grasperoperable to grasp the distal end of the tube, with the grasper extendingfrom the distal end of the tube, proximally through the tube, andextending out the proximal end of the tube where the handle may beoperated by the surgeon to grasp the distal edge of the tube. Each ofthe embodiments may also include a hoop fixed to the tube at its distalend, in a casing or otherwise, or may include inflatable channelsextending lengthwise along the tube, to serve as a means of holding thedistal end of the tube open, at least partially, while a specimen isdeposited within the tube.

The several methods described above may be broadly described as a methodof retrieving a tissue specimen from an endoscopic workspace in the bodyof a patient with the steps of inserting a tube through an opening tothe workspace, and into the endoscopic workspace, so that a distal endof the tube is disposed in the workspace and a proximal end of the tubeis disposed outside the workspace, placing the tissue specimen insidethe tube and everting the distal end of the tube by drawing the distalend of the tube inside the remainder of the tube and pulling said distalend proximally within the tube, to isolate the specimen from theworkspace, and then pulling the tube, after everting the distal end,through the opening, to remove the specimen and the tube from theworkspace. The benefits of the method of removing a specimen within asurgical workspace by drawing it into a tube, everting or partiallyeverting the tube to capture the specimen between an everted portion ofthe tube and an un-everted portion of the tube, and then withdrawing theeverted tube from the surgical workspace can be achieved with any of thedisclosed means for everting the tube, and any of the means for holdingthe tube open so that it may receive the specimen.

While the preferred embodiments of the devices and methods have beendescribed in reference to the environment in which they were developed,they are merely illustrative of the principles of the inventions. Theelements of the various embodiments may be incorporated into each of theother species to obtain the benefits of those elements in combinationwith such other species, and the various beneficial features may beemployed in embodiments alone or in combination with each other. Otherembodiments and configurations may be devised without departing from thespirit of the inventions and the scope of the appended claims.

We claim:
 1. A specimen retrieval system comprising: a tube having adistal end and a proximal end, said distal end being open, said tubehaving a lumen extending from the distal end to the proximal end; atether fixed to the distal end of the tube, said tether extending fromthe distal end of the tube and extending out the proximal end of thetube, said tether operable to pull the distal end of the tube while thedistal end of the tube is in an open configuration.
 2. The specimenretrieval system of claim 1 further comprising: means for holding thedistal end of the tube in an open configuration.
 3. The specimenretrieval system of claim 2, wherein the means for holding the distalend of the tube in an open configuration comprise one or more inflatablechannels extending longitudinally along the tube.
 4. The specimenretrieval system of claim 2, wherein the means for holding the distalend of the tube in an open configuration comprise a semi-rigid hoopsecured to a distal edge of the tube.
 5. The specimen retrieval systemof claim 4, wherein the tether is fixed to the distal end of the tubethrough the hoop.
 6. The specimen retrieval system of claim 2, whereinthe means for holding the distal end of the tube in an openconfiguration comprise a grasper extending through the tube, from theproximal end of the tube to the distal end of the tube.
 7. The specimenretrieval system of claim 1 further comprising: a casing disposed nearthe distal end of the tube; wherein a first portion of the tether runsthrough the casing.
 8. The specimen retrieval system of claim 1 furthercomprising: a plurality of inflatable channels disposed within a wall ofthe tube, said inflatable channels oriented longitudinally along thetube.
 9. The specimen retrieval system of claim 3 wherein: oneinflatable channel is separated from a second, adjacent inflatablechannel by a circumferentially extending region of the tube which is notinflatable.
 10. The specimen retrieval system of claim 3 wherein: theinflatable channels terminate at a point proximal to the distal end ofthe tube, thereby defining a skirt at the distal end of tubeun-supported by the inflatable channels.
 11. The specimen retrievalsystem of claim 3 wherein: the tube comprises a tube distal portion anda tube proximal portion, and the tube distal portion is isodiametric,and the inflatable channels are dispersed about the circumference of thetube, and terminate at a point proximal to the distal end of the tube,thereby defining a skirt at the distal end of the tube un-supported bythe inflatable channels.
 12. The specimen retrieval system of claim 3wherein: the tube comprises a tube distal portion and a tube proximalportion, and the tube distal portion is isodiametric, 10 to 14 incheslong, and 4 to 6 inches wide when un-inflated and laid flat, and theinflatable channels are ½ to 2 inches wide, dispersed about thecircumference of the tube, and terminate at a point proximal to thedistal end of the tube, thereby defining a skirt at the distal end ofthe tube un-supported by the inflatable channels.
 13. The specimenretrieval system of claim 3 wherein: the tube comprises a first, outertube and a second, inner tube, and the inner tube is secured to theouter tube to create a plurality of inflatable chambers separated byun-inflatable regions.
 14. The specimen retrieval system of claim 3further comprising: an aperture in each inflatable channel, saidaperture sized and dimensioned to allow fluid in each inflatable channelto leak from each inflatable channel at a rate lower than the rate atwhich inflatable channel is inflated.
 15. The specimen retrieval systemof claim 13 wherein the first tube comprises a nylon film, coated withurethane, and coated with silicon, and the first tube and the secondtube are heat sealed together.
 16. The specimen retrieval system ofclaim 3 further comprising a manifold in fluid communication with eachof the inflatable channels.
 17. The specimen retrieval system of claim 1further comprising: a rod having a blunt rounded distal tip.
 18. Thespecimen retrieval system if claim 17 further comprising: a second,semi-rigid guide ring located on the distal end of the rod and theproximal end of the stick extending out of the proximal end of the bag.19. The specimen retrieval system of claim 18 wherein, the guide ring isresiliently deformable and operable to be compressed to a smallconfiguration.
 20. The specimen retrieval system of claim 1 wherein, thedistal end of tube is folded to the inside of the tube to form aneverted cuff.